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Optical Trocar, 12 x 100mm

EUDAMED

Class IIa (EU MDR)

Ref PS5526Model TF-1019

by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited

Identity

Trade Name
Optical Trocar, 12 x 100mm EUDAMED
Device Name
Optical Trocars EUDAMED
Model / Reference
TF-1019 EUDAMED
PS5526 EUDAMED

Identifiers

Primary DI / UDI-DI
05051223027904 EUDAMED
Basic UDI-DI
B-05051223027904 EUDAMED
EMDN Code
K01010103 OPTICAL TROCAR, SINGLE-USE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Optical Trocar, 12 x 100mm by Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Purple Surgical Holdings Limited also known as Purple Surgical International Limited, Purple Surgical UK Limited and Purple Surgical Manufacturing Limited
EUDAMED SRN
GB-MF-000012819
Authorised Representative
Advena Limited MT-AR-000000234

Sources (1)

  • EUDAMED e8515245-12d5-48bf-bacf-c067287c527b 61 fields · synced Oct 7, 2026